Drug recall D-0087-2023

Class II Ongoing reported Dec 28, 2022

Product

Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01

Reason for recall

Failed Impurities/Degradation Specifications

Lots and codes

Lots: 01422002A1, Expiry: 12/2023; 01421078A3, Expiry: 09/2023

Recall details

Recalling firm
Aurolife Pharma, LLC, Dayton, NJ
Quantity
7344 bottles
Distribution
Nationwide in the USA and Puerto Rico.
Type
Voluntary: Firm initiated
Recall initiated
December 16, 2022

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